ADVIA Centaur® Systems HBc IgM QC 00504945

GUDID 00630414470504

HBc IgM (aHBcM) Quality Control Material Kit

Siemens Healthcare Diagnostics Inc.

Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
Primary Device ID00630414470504
NIH Device Record Key742d0210-a277-4ee4-88f9-cf12308b3f96
Commercial Distribution StatusIn Commercial Distribution
Brand NameADVIA Centaur® Systems HBc IgM QC
Version Model Number10308979
Catalog Number00504945
Company DUNS064608573
Company NameSiemens Healthcare Diagnostics Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414470504 [Primary]
GS100630414470504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LOMTest, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
LOMTest, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-24

Devices Manufactured by Siemens Healthcare Diagnostics Inc.

00630414556093 - ADVIA Centaur® SHBG Calibrator2020-05-12 SHBG - CENTAUR - CAL - 2x2x2mL
00630414286143 - RAPIDPoint® 500e Blood Gas System2020-04-23 The RAPIDPoint® 500e Blood Gas System is a compact, bench-top analyzer designed for in vitro diagnostic testing and issuitable
00630414285320 - Atellica CH UCFP Calibrator2020-03-17 Atellica CH UCFP Calibrator
00630414285313 - Atellica CH UCFP2020-03-17 Atellica CH UCFP Reagent
00630414285245 - ADVIA Chemistry UCFP2020-03-16 ADVIA Chemistry UCFP Reagent
00630414279183 - ADVIA Chemistry UCFP Calibrator2020-03-16 ADVIA Chemistry UCFP Calibrator
00630414247007 - ADVIA Centaur Zika IgM 50T2020-03-03 Zika IgM ADVIA Centaur Assay Kit 50T
00630414247014 - ADVIA Centaur Zika IgM QC2020-03-03 Zika IgM ADVIA Centaur Quality Control Material Kit 2 x 2 x 2.0 mL

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.